July 2018
Volume 59, Issue 9
Open Access
ARVO Annual Meeting Abstract  |   July 2018
Influence of perfluorohexyloctane containing eye drops on tear film thickness in patients with mild to moderate dry eye disease
Author Affiliations & Notes
  • Gerhard Garhofer
    Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria
  • Doreen Schmidl
    Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria
  • Rene Marcel Werkmeister
    Center for Medical Physics and Biomedical Engineering, Medical University of Vienna, Austria, Vienna, Austria
  • Narine Adzhemian
    Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria
    Moscow Helmholtz Research Institute of Eye Diseases, Moscow, Russian Federation
  • Kosobokovs Serge
    Novaliq GmbH, Heidelberg, Germany
  • Sonja Kroesser
    Novaliq GmbH, Heidelberg, Germany
  • Leopold Schmetterer
    Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria
    Singapore Eye Research Institute, Singapore National Eye Centre, Singapore, Singapore
Investigative Ophthalmology & Visual Science July 2018, Vol.59, 941. doi:
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      Gerhard Garhofer, Doreen Schmidl, Rene Marcel Werkmeister, Narine Adzhemian, Kosobokovs Serge, Sonja Kroesser, Leopold Schmetterer; Influence of perfluorohexyloctane containing eye drops on tear film thickness in patients with mild to moderate dry eye disease. Invest. Ophthalmol. Vis. Sci. 2018;59(9):941.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : NovaTears® (a new topical water-free eye drop containing perfluorohexyloctane, has been demonstrated to improve clinical signs and symptoms in patients with dry eye diseases (DED). In the present study, the effect of NovaTears®, on tear film thickness (TFT) in patients with mild to moderate DED was investigated.

Methods : A total of 48 patients with mild to moderate DED were included in this randomized, single-masked, observer-blinded parallel group study. Patients were randomized to receive either NovaTears®, or unpreserved 0.9% saline solution eye drops 4 times daily in both eyes for 4 weeks. TFT was assessed before treatment start and 6 times after first instillation to determine short time effect as well as after 2 and 4 weeks, respectively. A custom built and validated ultra-high resolution OCT system was used to assess TFT, the primary endpoint of the study. The precorneal lipid layer thickness (LLT) was measured based on a commercially available white-light interferometer. Further, standard clinical tests to assess signs and symptoms including break up time (BUT), fluorescein staining and ocular surfaces disease index (OSDI) were performed.

Results : Mean TFT and LLT at baseline were comparable in the two treatment groups. The primary efficacy analysis showed that the relative change (%) in TFT from baseline was significantly higher with NovaTears® than the comparator over all post-dose measures. After a single dose on Visit 1, NovaTears® temporarily increased TFT immediately after drop instillation. After multiple dosing, NovaTears® gradually increased TFT over time with a maximum effect at the end of the study after 4 weeks treatment (LS mean difference: 1.29%; p=0.4901 at Day 1, 4.33%; p=0.0547 at Week 2, 6.42%; p=0.0142) at week 4). LLT values recorded before drop instillation showed a more pronounced increase in LLT for NovaTears® (NovaTears®: 13.36%±26.33% saline: 3.21%± 28.65%; p=0.001). Fluorescein staining, BUT and OSDI improved in both treatment groups with no statistical difference between groups.

Conclusions : The study demonstrates that NovaTears® increases TFT as well as LLT over time and reached its maximum at the end of study treatment. These tear film restoring properties are in line with the mode of action of NovaTears® preventing evaporation by stabilizing the lipid layer.

This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.

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